Clinical trials: Palbociclib, completed
Melanoma
Biomarker-driven Therapy for Melanoma
Patients included will undergo biopsy and the molecular analysis will be discussed at the institutional molecular tumor board. The recommandation of the molecular tumor board will be provided to the physician in charge of the…
- Trial name
- TREAT20plus (NCT05063058)
- Testing
- Molecular guided therapy
- Volunteers
- 100 people
- Sponsor
- Charite University, Berlin, Germany
Neoplasms, Breast Neoplasms
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary…
- Trial name
- NCT01684215
- Testing
- PD-0332991, letrozole
- Where
- 16 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Pfizer
Breast Neoplasms
A Study to Learn About How Medicines Called CDK4/6 Inhibitors Are Used in People With Advanced or Metastatic Breast Cancer in Australia
The purpose of this study is to learn about how a class of medicines called CDK4/6 inhibitors, are used for the treatment of breast cancer in patients in Australia.
- Trial name
- ROSIE (NCT06624020)
- Where
- Australia
- Volunteers
- 1,128 people
- Sponsor
- Pfizer
Prostate Cancer
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer.
- Trial name
- NCT02059213
- Testing
- Ibrance, Bicalutamide, Zoladex
- Where
- 8 sites in United States
- Volunteers
- 72 people
- Sponsor
- University of Michigan Rogel Cancer Center
Breast Cancer
Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of…
- Trial name
- NCT04460911
- Where
- United States
- Volunteers
- 317 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national…
- Trial name
- NCT05132101
- Testing
- Patients who received Palbociclib as first line therapy in MBC setting
- Where
- South Korea
- Volunteers
- 2,758 people
- Sponsor
- Pfizer
Breast, Neoplasm Malignant
Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy
This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients.
- Conditions
- Breast, Neoplasm Malignant, Female
- Trial name
- NCT04524728
- Testing
- Palbociclib, Letrozole 2.5mg, Fulvestrant
- Where
- Italy
- Volunteers
- 191 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Metastatic Breast Cancer, Hormone Receptor Positive
A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer
This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to…
- Trial name
- NCT02384239
- Testing
- Palbociclib, Tamoxifen, Fulvestrant
- Where
- 9 sites in United States
- Volunteers
- 70 people
- Sponsor
- University of California, San Francisco
Renal Impairment
Study Of Palbociclib (PD-0332991) In Renal Impairment
Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib.
- Trial name
- NCT02085538
- Testing
- palbociclib
- Where
- 3 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Pfizer
Untreated Operable Early Breast Cancer
Randomized Phase II Study to Assess PD 0332991 in Breast Cancer
This is a Phase II study trying to identify whether short term treatment with PD0332991 yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at surgery- or induces senescence as determined by SABG…
- Trial name
- POP (NCT02008734)
- Testing
- PD0332991
- Where
- France
- Volunteers
- 132 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or…
- Conditions
- Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8
- Trial name
- NCT03981614
- Testing
- Binimetinib, Palbociclib, Trifluridine and Tipiracil Hydrochloride
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Academic and Community Cancer Research United
Breast Cancer
Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy
The study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with HR+/HER2- A/MBC who received palbociclib combination therapy with AI as first-line…
- Trial name
- NCT04394247
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Pfizer
Breast Cancer
A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors
The aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated…
- Trial name
- NCT07512063
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer
Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.
The purpose of this study is to determine the efficacy and the toxicities of the study drug PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype retinoblastoma protein (RB) and inactivated…
- Trial name
- NCT01291017
- Testing
- PD0332991
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- University of Florida
Acute Myeloid Leukemia, AML
Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia
The purpose of this study is to evaluate the safety and tolerability of Palbociclib in combination with investigational (experimental) drug, CPX-351 and evaluate the efficacy of Palbociclib in combination with chemotherapy as…
- Trial name
- NCT03844997
- Testing
- Palcociclib, CPX-351
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sudipto Mukherjee, MD, PhD, MPH
Breast Cancer, Hormonreceptor Positive
A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women…
- Conditions
- Breast Cancer, Hormonreceptor Positive, Her2-normal, Postneoadjuvant Treatment With CDK 4/6 Inhibitor
- Trial name
- PENELOPE-B (NCT01864746)
- Testing
- Palbociclib PD-0332991
- Where
- 11 sites in United States, Australia and 9 more
- Volunteers
- 1,250 people
- Sponsor
- GBG Forschungs GmbH
Hormone Receptor Positive HER-2 Negative Breast Cancer
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer.
- Trial name
- PALINA (NCT02692755)
- Testing
- Palbociclib + Letrozole or Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Georgetown University
Metastatic Breast Cancer
Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer
PATRICIA is a phase II, open-label, multicentre, Simon's two-stage-design study of the combination of palbociclib plus trastuzumab, with or without letrozole, in post-menopausal patients with HER2-positive locally advanced or…
- Trial name
- PATRICIA II (NCT02448420)
- Testing
- Palbociclib, Trastuzumab, Endocrine therapy
- Where
- 35 sites in Spain
- Volunteers
- 73 people
- Sponsor
- SOLTI Breast Cancer Research Group
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes…
- Conditions
- Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma, Recurrent Ewing Sarcoma, Recurrent Glioma
- Trial name
- NCT03526250
- Testing
- Laboratory Biomarker Analysis, Palbociclib, Pharmacological Study
- Where
- 117 sites in United States, Puerto Rico
- Volunteers
- 23 people
- Sponsor
- National Cancer Institute (NCI)
Solid Tumors, NSCLC
A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor…
- Conditions
- Solid Tumors, NSCLC, CRC, KRAS Gene Mutation
- Trial name
- NCT03965845
- Testing
- Telaglenestat (CB-839), Palbociclib Oral Capsule or Tablet [Ibrance]
- Where
- 10 sites in United States
- Volunteers
- 53 people
- Sponsor
- Calithera Biosciences, Inc